Antimicrobial hydrocolloid dressing containing sequestered peroxide and preparation thereof

ABSTRACT

This disclosure provides a hydrocolloid having a super absorbent material chemically bonded either directly or indirectly to a peroxide. The peroxide is within the hydrocolloid and the peroxide is in an amount of 0.05% to 2% by weight within the hydrocolloid.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/693,687, filed on Nov. 25, 2019, which is a continuation of U.S.application Ser. No. 14/540,911, filed on Nov. 13, 2014, now U.S. Pat.No. 10,485,893, both of which are hereby incorporated by reference intheir entirety and are to be considered as a part of this specification.

REFERENCE REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

Not Applicable

SEQUENCE LISTING

Not Applicable

BACKGROUND Field of the Disclosure

The present disclosure is related to advanced wound care, incontinencecare, catheter securement, and ostomy devices to be attached to a humanbody through an adhesive. The adhesive is a biomedical polymer materialthat incorporates sequestered peroxide as an antimicrobial agent.

Description of the Related Art

Advanced wound care, incontinence care, and ostomy care devices are wellknown in the market place. Typically, these devices are attached via askin friendly adhesive, such as a hydrocolloid, acrylic, silicone, etc.

For example, U.S. Pat. No. 4,551,490 discloses pressure sensitiveadhesive compositions particularly adapted for use in the fields ofincontinence, ostomy care, wound care, and burn care dressings.Similarly, other prior art devices such as those described in U.S. Pat.Nos. 3,339,546, 3,612,053, 4,166,051, 4,184,635, 4,192,785, 4,231,369,4,393,150, 4,393,080, 4,496,357, 4,743,499, 5,492,943, and 6,143,798,also disclose such compositions as well.

Superabsorbent materials comprising peroxide are disclosed in U.S. Pub.No. 2010/0247615. This publication pertains to a polymeric compositionand an antimicrobial composition that combine to form an antimicrobialsuperabsorbent polymer used within diapers and other sanitary products.

Antimicrobial pressure sensitive adhesives and the uses thereof are alsowell known and described in U.S. Pat. Nos. 5,569,207, 5,681,579,6,468,521, 5,554,106, and 6,884,920.

SUMMARY

The present disclosure is based on the discovery that peroxides bound topolymers, oligomers, and/or matrices can maintain antimicrobialefficacy, and that these substrates act as stabilizers of the peroxidespecies. Therefore, the peroxide concentrations can be significantlyreduced, thus minimizing deleterious effects normally found whenapplying a peroxide to an open wound. In addition, these stabilized andactive peroxide species can be formulated with typical hydrocolloidmaterials to produce skin friendly pressure sensitive adhesives tominimize the bioburden within the adhesive and provide a hygienicenvironment.

In general, the antimicrobial hydrocolloid laminate in the presentdisclosure includes an extruded mass of adhesive between two or moresubstrates, release liners, or laminated liners. The subsequentintermediate is converted, cut, or transformed to create antimicrobialwound care dressings, wound care foams, ostomy devices, incontinenceadhesives, devices which secure catheters, and the like.

In one aspect, the present disclosure provides a hydrocolloid includinga super absorbent material chemically bonded either directly orindirectly to a peroxide, wherein the peroxide is within thehydrocolloid and the peroxide is in an amount of 0.05% to 2% by weightwithin the hydrocolloid.

In some embodiments, the peroxide is added to the hydrocolloidcomposition during processing at a temperature below 99° C., and thehydrocolloid may be capable of absorbing liquid and forming a gelmatrix. The super absorbent material chemically bonded to the peroxidemay also be about 0.50% to 20.00% by weight of the hydrocolloid, and thehydrocolloid may include at least one of a water soluble polymer, ahydrocolloid gum, or a combination thereof.

In other embodiments, the hydrocolloid may include a carboxymethylcellulose. In some embodiments, the carboxymethyl cellulose is 17.25% to32.75% by weight of the hydrocolloid. In further embodiments, the superabsorbent material is a cross-linked sodium carboxymethyl cellulose, acrystalline sodium carboxymethyl cellulose, or a combination thereof,and the hydrocolloid further includes a pressure sensitive adhesive, athermoplastic elastomer, and a liquid rubber. In even furtherembodiments, the hydrocolloid includes a metal salt, and the chemicalbond between the super absorbent material and the peroxide may be anindirect bond, wherein the metal salt is an intermediate bridge betweenthe super absorbent material and the peroxide. In these embodiments, themetal salt may be a zinc salt.

According to another aspect, the present disclosure provides a method ofpreparing a hydrocolloid adhesive. The method includes the steps ofmixing one or more components to produce a first phase; mixing one ormore components to produce a second phase, wherein the second phaseincludes a super absorbent material chemically bonded to a peroxide;mixing the components of the first phase and the second phase to producea uniform mixture at a temperature below 99° C.; and forming the uniformmixture into a hydrocolloid adhesive. Further, the peroxide is 0.05% to2% by weight of the hydrocolloid adhesive.

In some embodiments, the step of adding the discontinuous phase to thecontinuous phase includes adding the peroxide in an amount to producethe hydrocolloid adhesive with 0.05% to 2.0% by weight of the peroxide.Further, in these embodiments, the step of mixing one or more componentsto produce a continuous phase may include mixing a thermoplasticelastomer, a polyisobutylene, and a liquid rubber. Additionally, themethod may also include the steps of adding an oil at a temperaturebetween about 135° C. to about 110° C.; adding a tackifier at atemperature between about 110° C. to about 95° C.; and adding aplasticizer at a temperature between about 105° C. to about 90° C.

In further embodiments, the components of the discontinuous phase alsoincludes the super absorbent material and a metal salt. In theseembodiments, the method further includes the step of producing astabilized combination of the super absorbent material, the metal salt,and the peroxide, wherein the super absorbent material is chemicallybonded to the peroxide. The method may also include the steps of heatingthe first phase to a predetermined temperature between about 135° C. to170° C.m, and the step of reducing a temperature of the first phase to asecond predetermined temperature below 99° C., wherein the step ofreducing a temperature of the first phase to a second predeterminedtemperature below 99° C. may be prior to the step of mixing thecomponents of the first phase and the second phase to produce a uniformmixture.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-F depict results of a 1″ adhesive patch (30 mil thick) placedon a plate coated with E. coli to test the zone of inhibition causedthereby, of which, FIG. 1A=a 0.05% peroxide in the adhesive formulation,FIG. 1B=a 0.10% peroxide in the adhesive formulation, FIG. 1C=a 0.20%peroxide in the adhesive formulation, FIG. 1D=a 0.40% peroxide in theadhesive formulation, FIG. 1E=a 0.80% peroxide in the adhesiveformulation, and FIG. 1F=a 2.00% peroxide in the adhesive formulation;

FIGS. 2A-F depict results of a 1″ adhesive patch (30 mil thick) placedon a plate coated with MRSA to test the zone of inhibition causedthereby, of which, FIG. 2A=a 0.05% peroxide in the adhesive formulation,FIG. 2B=a 0.10% peroxide in the adhesive formulation, FIG. 2C=a 0.20%peroxide in the adhesive formulation, FIG. 2D=a 0.40% peroxide in theadhesive formulation, FIG. 2E=a 0.80% peroxide in the adhesiveformulation, and FIG. 2F=a 2.00% peroxide in the adhesive formulation;

FIG. 3 depicts results of a 1″ adhesive patch (30 mil thick) placed on aplate coated with MRSA to test the zone of inhibition caused thereby.The adhesive had no peroxide (control);

FIG. 4 depicts a device incorporating a metal salt peroxide superabsorbent polymer adhesive formulation according to one embodiment; and

FIG. 5 depicts a blank incorporating a metal salt peroxide superabsorbent polymer adhesive formulation according to one embodiment.

DETAILED DESCRIPTION

There are many well-known prior art antimicrobial adhesive compositionsfor wounds that reduce microbial proliferation and reduce hospitalacquired infections, such as those including antiseptics anddisinfectants. However, the present disclosure provides for compositionsof pressure sensitive adhesives that contain sequestered and stableperoxides. These new compositions may be used with advantageous resultsas an antimicrobial pressure sensitive adhesive, a wound treatment, suchas a hydrocolloid dressing or foam dressing, and/or an antimicrobialtreatment for ostomy and incontinence applications.

The wound bed itself offers an attractive environment in which bacteriaand other microbes can flourish, which complicates normal wound healing.Therefore, managing a wound with antibiotics or antimicrobials tominimize infection would be a logical treatment. However, there are manypotential and adverse effects associated with the clinical use ofantibiotics and antimicrobials, such as allergic reactions, heavy metalpoisoning, and destruction of proliferating tissue, which can result inslow wound closure and other complications. The degree to which theseadverse effects may be realized is usually dependent on theconcentration of the antimicrobial agent administered. One importantadverse side effect of antibiotics is the emergence of antibioticresistant microorgansisms, MRSA for example. The emergence ofantibiotic-resistant pathogens is a serious threat to controllinginfections and provides a convincing reason to develop new therapiesdesigned to effectively prevent and treat bacterial infections.

Some antimicrobial treatments include silver-containing gels, compoundscontaining heavy metals, solutions of hydrogen peroxide, and othernatural substances. Silver ions disrupt bacterial enzymes and thusinhibit bacterial growth. The interaction of silver ions with thiolgroups (sulfur or —SH groups) in enzymes and proteins is believed toplay an essential role in its antimicrobial action. Disruption ofcritical enzymes and proteins may lead to inhibited cell division,damaged cellular envelopes, and lysing of bacterial cells. Similarly, ahigh level of hydrogen peroxide has toxic effects. Hydrogen peroxideinhibits bacterial growth by oxidizing cellular components. Reactiveoxygen species bind or modify DNA, proteins, and lipids. However, athigh concentrations, hydrogen peroxide reduces wound healing byimpacting connective tissue formation and wound closure throughincreases in matrix metalloproteinase levels. An additional obstaclewith the use of hydrogen peroxide, is that it is typically used insolutions where it is unstable and difficult to provide a sustaineddelivery system for broad spectrum antimicrobial use.

For more than 30 years, pressure sensitive adhesives, such ashydrocolloids, have been used for the safe and effective treatment ofwounds, as well as the attachment of ostomy devices, catheters, andincontinence devices. Hydrocolloids are occlusive, moisture-retentivedressings that absorb wound exudates, form a gel, and have been shown tohave the beneficial effects of reducing the chances ofcross-contamination by trapping bacteria within the gel matrix. Addingan antimicrobial agent within the matrix may provide additionalbacterial growth control within the dressing to further reduce theincidence of cross-contamination and bioburden within the dressing.

Throughout the last decade, several silver containing pressure sensitiveadhesives have been approved and cleared by the FDA, which arecomparable to non-antimicrobial devices within these markets.Antimicrobial silver dressings have been repeatedly shown to be safe andeffective, regardless of significant potential cytotoxic effects on thewound bed. Nevertheless, over the past few years, silver-based pressuresensitive adhesives have been abandoned due to the high cost ofmanufacturing, the lack of a higher reimbursement, as well as thepotential negative impact on wound healing.

Today, a lack of effective antimicrobial agents within pressuresensitive adhesives creates a significant gap in patient care and posesa threat of serious complications. Caregivers do not have anantimicrobial skin friendly adhesive to aid in advanced wound healingfor a patient, or to secure another medical device. Moreover,application of conventional topical antibiotics prior to application ofadhesives may be counter indicated or otherwise decrease theeffectiveness of the adhesives. An antimicrobial hydrocolloid wouldminimize the risk of microbial proliferation and cross-contamination.

As noted above, uncontrolled applications of high concentrations ofperoxide can be deleterious to a proliferating wound bed. However, astable hydrogen peroxide that has a controlled release can be used atlower concentrations, while maintaining its antimicrobial efficacy andproviding additional benefits. At low concentrations, hydrogen peroxidepromotes wound closure, increases the formation of blood vessels, andmaintains normal MMP levels. Recent work has demonstrated that hydrogenperoxide can promote neural axon regeneration. After injury of the skin,cells produce hydrogen peroxide to attract neutrophils, which increasesneutrophil activity and promotes a healthy wound bed. Studies thatremove the low levels of natural hydrogen peroxide in the wound bytreating with catalase, show reduced wound healing and reduced bloodvessel formation.

The present compositions of antimicrobial pressure sensitive adhesivesprovide a platform for applications within the medical field to reducehospital acquired infections, decrease the bioburden under devicesattached to the skin, increase the cleanliness of a given therapy, andreduce odor associated with many applications.

Materials that may be used for sequestration of peroxides include anysuitable material that may be applied to a subject in need thereof. Inone embodiment, superabsorbent materials are contemplated. Contemplatedsuperabsorbent materials (SAMs) include those that are soluble,insoluble, powder-based, film-forming, gel-forming, complexes,copolymers, fibers, etc. Specific SAMs that are contemplated includepolyacrylates, alginates, cellulose derivatives (such ascarboxylmethycellulose), or any polymer that contains a reactive groupthat bonds to a peroxide or to another reactive intermediate and forms abridge with a peroxide containing component. Other reactiveintermediates suitable for use in this disclosure include salts or othercomponents or compounds that have the ability to sequester peroxide tothe SAMs in a stable composition. Salts suitable for use within thisdisclosure include, for example, salts of zinc, copper, silver,zirconium, or magnesium.

Useful peroxide sources may include hydrogen peroxide, benzoyl peroxide,or a means for generating peroxide in the form of a stable antimicrobialand immunostimulatory system. For example, a system may include anoxidoreductase enzyme, a substrate for the oxidoreductase enzyme, andother cofactors that lead to the production of a stable peroxideavailable for sequestration within the adhesive mass prior to or duringits manufacture.

Adhesive formulations in this disclosure have numerous applications. Forexample, adhesive formulations of the present disclosure may be used inconjunction with wound care devices that provide a moist wound healingenvironment. It is believed that the contemplated hydrocolloids,alginates, foams, and bordered dressings that include a sequesteredperoxide compound benefit the patient by reducing the bacterial load andpotentially provide additional benefits in healing rates anddebridement.

For example, ostomy devices that collect waste and are attached to thebody via a contemplated hydrocolloid adhesive would have several patientbenefits. These ostomy devices with sequestered peroxide would reduceodor, increase hygiene, and reduce the bacterial and fungal loadnormally associated with the use of these devices. Thus, one-pieceostomy systems, two-piece collection systems, and urostomy collectionsystems that include the disclosed adhesive would benefit the patient.In addition to collection devices themselves, additional ostomyaccessories such as pastes, sealants, sealing rings, and adhesive stripsthat include the disclosed adhesive would create a contiguous systemthat would benefit the user.

In another example, catheters are used to treat medical diseases and areintegral components for patient care in clinical/hospital settings. Inall cases, traditional adhesive tapes are used to secure catheters tothe body. The adhesive disclosed in this application would provide anantimicrobial environment around and over the breeched skin, thusreducing cross infection and potentially life threatening complications.In terms of external catheters and incontinence devices, the disclosedadhesive would provide a clean and hygienic environment to minimize odorand reduce additional damage to the skin with a skin friendly adhesive.Thus, tapes or bandages used to secure these devices could be createdwith the disclosed adhesives in this application. Specific examples arediscussed below in the Examples.

EXAMPLES Example No. 1—Formulation of a Contemplated Adhesive

Hydrocolloid adhesive formulas are well known, but hydrocolloids thatcontain antimicrobial agents, astringents, or broad spectrum agentsother than silver are not. Typically, hydrocolloid formulations andmanufacturing are not compatible with commonly used antimicrobials orbroad spectrum agents since they are less stable. Our goal was todevelop a hydrocolloid formulation that could employ peroxide as a broadspectrum agent. Given the unstable nature of peroxides, the highmolecular weight components within an adhesive, and the temperatureprofile of a typical manufacturing process, we did not believe that wewould be successful.

Hydrocolloid adhesives utilize a continuous phase and discontinuousphase. The continuous phase may contain a mixture of a permanently tackypressure sensitive adhesive, a styrene-containing thermoplasticelastomer, a liquid rubber, a low molecular weight polyisobutylene,stabilizers, and a low molecular weight liquid polybutene in variousamounts and in various combinations. When thermoplastic elastomers areemployed as integrating agents, which holds the other high molecularweight components together, high temperatures, in excess of 350° F., arerequired to meld these components.

The discontinuous phase contains one or more water soluble and/or waterswellable absorbent polymers (SAP) such as carboxymethylcellulose (CMC),zinc, hydrocolloid gums, etc. Once the continuous phase is homogenous,then the discontinuous components are added all at once, or in atemporal fashion with corresponding drops in the temperature of themixture. If the discontinuous phase is too hot, then adding peroxidecontaining materials could cause an uncontrollable exothermic reactionand lead to the demise of the adhesive and removal of the antimicrobialefficacy.

Suitable thermoplastic styrene-containing elastomers include blockcopolymers based on styrene-butadiene, styrene-isoprene or styreneethylene-butylene. Also, a low styrene synthetic copolymer of butadieneand styrene, commonly called SBR rubber, can be used as thethermoplastic elastomer. The elastomer may consist of linear or radialA-B-A block copolymers or mixtures of these A-B-A copolymers with simpleA-B block copolymers. The final adhesive composition may contain about 1wt. % to about 30 wt. % of this component.

Liquid rubbers contemplated herein include synthetic liquid isoprenerubber, hydroxyl terminated synthetic liquid isoprene rubber,hydrogenated liquid isoprene rubber, liquid isoprene-styrene copolymers,liquid isoprene-butadiene copolymers, and liquid butadiene-styrenecopolymers. The liquid rubbers typically have a molecular weight ofabout 25,000 to about 50,000. Preferably, the liquid rubbers have aglass transition temperature of less than about −50° C., and a meltviscosity at 38° C. of from about 500 to about 10,000 poises. Otherliquid rubbers known in the art could be useful in the continuous phase.The final adhesive composition should contain about 10 wt. % to about 55wt. % of these components.

The polyisobutylene component may comprise the Vistanex® LM series ofpolyisobutylenes, available from Exxon Chemical Corporation, and whichhave average molecular weights in the range of about 35,000 to about70,000 and viscosities within the range of about 20,000 to about 140,000mPa. The low molecular weight polybutene components may comprise theHyvis series of materials from BP and by the Parapol series of productsfrom Exxon, and may have molecular weights ranging from about 1000 toabout 3000. The final adhesive composition should contain about 2 wt. %to about 45 wt. % of these components.

Other ingredients such as a suitable processing stabilizer may also beincluded in the hot melt adhesive component. Examples include Irganox®1010, which is pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate). Further, tackifiers,oils, and plasticisers may be added to the continuous phase to modifytack and optimize adhesion properties. The final adhesive compositionmay contain about 0.5 wt. % to about 35 wt. % of these components.

The discontinuous phase may include one or more hydrophilicmoisture-absorbing polymers that are swellable in water solutions,including all body secretions. One or more swellable polymers may bepresent. Suitable swellable polymers include, for example, cross-linkedsodium carboxymethyl cellulose or crystalline sodium carboxymethylcellulose. The swellable polymer may also be a “super absorbent”material such as starch sodium polyacrylate. Suitable water solublepolymers may include sodium carboxymethyl cellulose, pectin, gelatin,guar gum, Arabica gum, locust bean gum, collagen, karaya gum, zinc,metal salts, and starch, and the like. The discontinuous phase shouldnot normally exceed about 65% of the total weight of the adhesive andmay be comprised of any combination of soluble and/or insolubleabsorbents.

Adhesive compositions may be prepared as follows. The thermoplasticelastomer, polyisobutylenes (PIBs), and the liquid rubber component areblended together in a suitable mixer, normally a sigma blade mixer withan extruder discharge. The mixer is heated to set to 135° C. to 170° C.About 1% of a suitable stabilizer, such as Irganox® 1010, should beadded at this stage. Once the thermoplastic elastomer, PIBs, liquidrubbers, and stabilizer blend, the mixer temperature is reduced to 75°C. At specific cooling temperature set points, the oils 135° C. and 110°C., tackifiers 110° C. and 95° C., and plasticizers 105° C. and 90° C.are added in a temporal manner. Once the mix is blended and cooledsufficiently to between about 75° C. and 99° C., the powderyhydrocolloid ingredients, metal salts, peroxide blends, etc. of thediscontinuous phase are added to the mixer. We have found that thestabilized combination of SAP, metal salt, and peroxide can be added ata temperature below 99° C. without loss of peroxide antimicrobialactivity along with the other discontinuous phase components. These areblended until uniform and the mixer temperature has dropped to about 80°C. At this stage, the fully mixed mass is then removed from the mixer.The mass may be extruded or pressed to the desired thickness whilelaminating it to suitable substrates to be die cut to shapes, if needed.

Several adhesive formulations that vary in % wt. concentration arerepresented in Table No. 1 below. It should be noted that theseformulations are representative and not inclusive of all envisionedcombinations.

TABLE No 1 Compo- Peroxide Peroxide Peroxide Peroxide Peroxide Peroxidenent 0.05% 0.1% 0.2% 0.4% 0.8% 2.0% Thermo-   9.00%   9.00%   9.00%  9.00%   8.00%   8.00% plastic Elas- tomer Rubber  13.00%  13.00% 13.00%  13.00%   8.00%   8.00% AO   0.50%   0.50%   0.50%   0.50%  0.50%   0.50% Tackifier   5.10%   5.10%   5.10%   5.10%   5.10%  5.10% PIB  22.00%  22.00%  22.00%  22.00%  33.00%  33.00% Oil  12.00% 12.00%  12.00%  12.00%   8.00%   8.00% Metal   0.50%   1.00%   2.00%  4.00%   8.00%  20.00% salt peroxide SAP CMC  32.75%  32.25%  31.25% 29.25%  29.25%  17.25% Gelatin   3.00%   3.00%   3.00%   3.00%   0.00%  0.00% Citrus   2.00%   2.00%   2.00%   2.00%   0.00%   0.00% PectinZinc   0.15%   0.15%   0.15%   0.15%   0.15%   0.15% Oxide 100.00%100.00% 100.00% 100.00% 100.00% 100.00%

Example No. 2—Antibacterial Efficacy Test for Different Metal SaltPeroxide SAP

In order to confirm the efficacy of the above formulations, we testedeach formulation's ability to kill Escherichia coli (E. coli) and MRSAwith 1″ die cut circles at 30 mil thickness. Each sample was testedagainst E. coli and MRSA using the agar slurry method. The inoculumlevel for these samples was higher by 6 logs (seeded at over 1×10⁶ cellsper plate).

Subsequently, one 1″ adhesive patch (30 mil thick) of each formulation(see Table No. 2) was placed on plates coated separately with E. coliand MRSA to test the zone of inhibition found with each formulation.These tests were incubated at 37° C. for 24 hrs and then photographed.Refer to Table No. 3 below and FIGS. 1A-F and 2A-F for efficacy resultsagainst EC and MRSA, respectively.

TABLE NO. 2 % Active within Adhesive % Active SAP added A) Peroxide0.05% 0.5% active (Mixed SAP with active peroxide, MSPO) B) Peroxide0.10%  1% active MSPO C) Peroxide 0.20%  2% active MSPO D) Peroxide0.40%  4% active MSPO E) Peroxide 0.80%  8% active MSPO F) Peroxide2.00% 20% active MSPO

TABLE NO. 3 Average Average Log Reduction Log Reduction Overnight t = 0Sample versus EC A) Peroxide 0.05% 7.70* ± 0.00 6.13* ± 0.00 B) Peroxide0.10% 7.70* ± 0.00 6.13* ± 0.00 C) Peroxide 0.20% 7.70* ± 0.00 6.13* ±0.00 D) Peroxide 0.40% 7.70* ± 0.00 6.13* ± 0.00 E) Peroxide 0.80% 7.70*± 0.00 6.13* ± 0.00 F) Peroxide 2.00% 7.70* ± 0.00 6.13* ± 0.00 Sampleversus MRSA A) Peroxide 0.05% 5.81* ± 0.00 5.76* ± 0.00 B) Peroxide0.10% 5.81* ± 0.00 5.76* ± 0.00 C) Peroxide 0.20% 5.81* ± 0.00 5.76* ±0.00 D) Peroxide 0.40% 5.81* ± 0.00 5.76* ± 0.00 E) Peroxide 0.80% 5.81*± 0.00 5.76* ± 0.00 F) Peroxide 2.00% 5.81* ± 0.00 5.76* ± 0.00*indicates full kill

As seen in Table No. 3, all samples showed full kill against both MRSAand E. coli.

The zone of inhibition surrounding the device is attributable to theactive MSPO concentration. In contrast, a control with 0% MSPO shown inFIG. 3 exhibited no inhibition of bacterial growth. Moreover, the zonesof inhibition of FIGS. 1A-F and 2A-F demonstrate that the differentmetal salt peroxide SAP formulations not only kill bacteria that theytouch, but they further create a zone of protection around a deviceincorporating the formulations. Thus, devices of the current disclosureincorporating the inventive formulations will provide improvedantibacterial functionality to subjects using the devices.

Example No. 3—Description of Creation of a Bandage or Other Device thatIncludes the Adhesive from Example No. 1

An example of a contemplated device 10 that includes an adhesiveformulation of Example No. 1 is shown in FIG. 4 . The device 10 mayinclude a central portion 12 that may be a sterile gauze-like or otherabsorptive material made of, for example, a cellulosic or plasticmaterial, and a peripheral portion 14 that may include an adhesiveformulation, as described herein. Alternatively, the central portion 12may constitute the metal salt peroxide SAP formulation and theperipheral portion 14 may be a backing material, such as a cellulosic orplastic material that provides a non-sticky surface. Additionalvariations are contemplated herein. The device 10 may have anydimensions, such as a square configuration, as shown, or may berectangular, triangular, oval-shaped, circular, and the like.

It is further envisioned that the device 10 may be custom designedeither by a printing and/or automated cutting device into whichindividualized dimensions for a particular purpose have been programmedvia computer or similar interface. Similarly, a blank 20 of thecontemplated adhesive material is envisioned, as shown in FIG. 5 . Theblank 20 may include pre-selected cutouts 22 defined by perforations 24and be used in various applications depending on the need. Any sizeand/or shape of blanks 20 and cutouts 22 are contemplated herein. Theblank 20 may further include one or two sides (for example, front andback sheets) of non-stick materials to allow sterile handling of theblank prior to use.

INDUSTRIAL APPLICABILITY

The formulations and devices described herein advantageously provideimprovements for advanced wound care, incontinence care, cathetersecurement, and ostomy devices to be attached to a human body through anadhesive.

Numerous modifications will be apparent to those skilled in the art inview of the foregoing description. Accordingly, this description is tobe construed as illustrative only and is presented for the purpose ofenabling those skilled in the art to make and use the invention and toteach the best mode of carrying out same. The exclusive rights to allmodifications which come within the scope of the application arereserved. All patents and patent publications are incorporated byreference.

I claim:
 1. A method of preparing a hydrocolloid adhesive, the methodcomprising the steps of: mixing one or more components to produce afirst phase; mixing one or more components to produce a second phase,wherein the second phase includes a super absorbent material chemicallybonded to a peroxide; mixing the components of the first phase and thesecond phase to produce a uniform mixture at a temperature below 99° C.;and forming the uniform mixture into a hydrocolloid adhesive, whereinthe peroxide is 0.05% to 2% by weight of the hydrocolloid adhesive. 2.The method of claim 1, wherein the step of adding the discontinuousphase to the continuous phase includes adding the peroxide in an amountto produce the hydrocolloid adhesive with 0.05% to 2.0% by weight of theperoxide.
 3. The method of claim 2, wherein the step of mixing one ormore components to produce a continuous phase comprises mixing athermoplastic elastomer, a polyisobutylene, and a liquid rubber.
 4. Themethod of claim 3, the method further including the steps of: adding anoil at a temperature between about 135° C. to about 110° C.; adding atackifier at a temperature between about 110° C. to about 95° C.; andadding a plasticizer at a temperature between about 105° C. to about 90°C.
 5. The method of claim 4, wherein the components of the discontinuousphase further comprise the super absorbent material and a metal salt. 6.The method of claim 5, wherein the method further comprises the step ofproducing a stabilized combination of the super absorbent material, themetal salt, and the peroxide, wherein the super absorbent material ischemically bonded to the peroxide.
 7. The method of claim 6, the methodfurther comprising the steps of heating the first phase to apredetermined temperature between about 135° C. to 170° C.
 8. The methodof claim 7, the method further comprising the step of reducing atemperature of the first phase to a second predetermined temperaturebelow 99° C.
 9. The method of claim 8, wherein the step of reducing atemperature of the first phase to a second predetermined temperaturebelow 99° C. is prior to the step of mixing the components of the firstphase and the second phase to produce a uniform mixture.